Vibration Response Imaging (VRI) in Lung Transplant Recipients
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|ClinicalTrials.gov Identifier: NCT00744822|
Recruitment Status : Completed
First Posted : September 1, 2008
Last Update Posted : September 1, 2008
|Condition or disease|
- Study participants will be patients who have undergone lung transplantation during the last 6 months and are in a stable clinical position at the time of enrollment.
- Patients who meet the study inclusion and exclusion criteria will be enrolled in the study.
The enrolled patients will be recorded with the VRI at each occurrence in which the standard procedures are performed:
- Baseline after study enrollment (VRI Recording 1 + standard evaluations).
- At each follow-up visit [1, 3, 6 months after baseline visit] during the 6 month follow-up period of the study (VRI Recordings + standard evaluations (if possible)).
- In the event of bronchoscopic intervention, then before the interventional procedure (VRI Recording 1 + standard evaluations) and before any recurrent interventional procedures (VRI Recordings + standard evaluations) during the course of the study (6-month follow-up period).
- 1 hour after all bronchoscopic interventional procedures.
- In the event of an unanticipated visit, then a VRI recording will be performed (VRI Recordings + standard evaluations).
- All subjects will be recorded according to a standard procedure; moreover, it is essential that for each subject repeatable recordings will be performed in the same manner (i.e. breathing manner and matrix placement). Each VRI recording session will take ~15 minutes [the actual recording is ~2 minutes for placement and breathing/recording].
Standard evaluation procedures may include any of the following:
- Lung function tests (this test is required at all visits)
- Physical examination
- Bronchoscopy (e.g. transbronchial biopsy)
- Chest x-ray
- V/Q Scan (Baseline visit for single lung transplantation)
- Blood gases (this test is required at all visits)
- Blood tests
|Study Type :||Observational|
|Actual Enrollment :||55 participants|
|Official Title:||Vibration Response Imaging (VRI) in Lung Transplant Recipients|
|Study Start Date :||March 2006|
|Actual Primary Completion Date :||March 2007|
|Actual Study Completion Date :||March 2007|
- The primary study objective is to evaluate the ability of VRI lung images in single lung or double lung transplant recipients to assist the physician in detecting risk factors associated with lung transplantation during the six-month follow-up period [ Time Frame: 6 months ]
- The secondary objective is to compare evaluations of the lung VRI images with the results of other evaluation techniques [i.e. PFT, chest X-ray]. [ Time Frame: 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00744822
|Hannover Medical School|
|Hannover, Germany, 30625|
|Principal Investigator:||Tobias Welte, MD||Hannover Medical School|